Bone plate shaping system

ABSTRACT

Removable guide tips are pre-assembled into threaded holes of a fracture fixation plate. The guide tips may be used with or without drill guides to guide a drill along the axes of threaded holes defined in the plate. In addition, the tips may be used with bending tools to contour the plate laterally, longitudinally and with twist. More particularly, such plate contouring can be performed while the plate is located on the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 11/459,824, filedJul. 25, 2006 now U.S. Pat. No. 7,935,126, which is acontinuation-in-part of U.S. Ser. No. 11/384,841, filed Mar. 20, 2006,now U.S. Pat. No. 7,771,433, both of which are hereby incorporated byreference herein in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to surgical devices. More particularly,this invention relates to orthopedic implants, and specifically toelements to implant and shape a bone plate.

2. State of the Art

Alignment and fixation of a fracture are typically performed by one ofseveral methods: casting, external fixation, pinning, and plating.Casting is non-invasive, but may not be able to maintain alignment ofthe fracture where many bone fragments exist. Therefore, as analternative, external fixators may be used. External fixators utilize amethod known as ligamentotaxis, which provides distraction forces acrossthe joint and permits the fracture to be aligned based upon the tensionplaced on the surrounding ligaments. However, while external fixatorscan maintain the position of the wrist bones, it may nevertheless bedifficult in certain fractures to first provide the bones in properalignment. In addition, external fixators are often not suitable forfractures resulting in multiple bone fragments. Pinning with K-wires(Kirschner wires) is an invasive procedure whereby pins are positionedinto the various fragments. This is a difficult and time consumingprocedure that provides limited fixation if the bone is comminuted orosteoporotic.

Plating utilizes a stabilizing metal plate typically placed against thebone, fixed-angle fasteners (which may have threaded or non-threadedshafts) positioned through the plate and entering drilled holes adjacentan articular bone surface, and cortical screws extending from the plateinto holes drilled in the bone to provide stabilized fracture fixation.For example, co-owned U.S. Pub. No. 20040193164 A1 to Orbay, which ishereby incorporated by reference herein in its entirety, discloses aplate particularly adapted to treat dorsally displaced metaphysealfractures from the volar side of the wrist.

When fixed-angle fasteners are utilized in conjunction with a boneplate, it is necessary to ensure that the pilot holes drilled for thefasteners are co-axial with the hole axes. Otherwise, the shaft of thefasteners will not properly align with the anatomy, and the head of thefasteners will not properly align with the threaded holes of the plate,potentially resulting in cross-threading. As a result, with the plateplaced upon the bone, prior to drilling each hole in the bone inalignment with a threaded hole, a drill guide is attached to the plateat the threaded hole. The guide defines a tubular passage which directsthe drill bit in the proper orientation for a fastener through theparticular threaded hole. After drilling each hole, the drill guide isremoved, the fastener is inserted in the threaded hole, and the drillguide is coupled to a subsequent threaded hole.

The process of attaching the drill guide during the surgical procedureis laborious. It can be difficult to locate the appropriate angle forthreadably coupling the guide to the peg hole during the procedure,given that each threaded hole may have a discrete axis angle from theother threaded holes. Such difficulty can unnecessarily prolong thesurgical procedure.

Fragment plates are commonly used to fixate fractures along a bone,e.g., along the diaphysis or at specific diaphyseal-metaphyseal ormetaphyseal locations. Such plates are generally elongate, L-shaped,Y-shaped or have another shape which is suited for placement on aportion of a bone. The plates can be of varying length depending uponthe intended fixation application. When fragment plates are providedwith threaded holes they are subject to the same practical laborintensity for use as presented above with respect to the volar plate;i.e., it is laborious to attach a drill guide at each threaded hole fordrilling a hole in alignment with the axis of the hole for receiving thefixed angle fastener therethrough.

In addition, the anatomy for which the fragment plates are designedoften differs from the exact contours of the bone contacting surfaces ofthe plates. Some fragment plates have been designed to be shaped awayfrom the bone for a better anatomical fit. However, presently availableplating systems are not well adapted for in situ reconfiguration.Therefore, it has been necessary to shape a plate off the target bonewith bending tools, remove the bending tools, place the plate inposition on the bone to which the plate will eventually be attached,approximate the additional amount of reconfiguring required, remove theplate, and repeat the process until the plate approximately conforms tothe shape of the bone. Moreover, in order to best fit the anatomy aplate may need to be re-contoured along three axes, and it has beendifficult to transfer the contours of the anatomy to a stiff metalplate, especially when such reshaping is done at a distance from thebone.

Moreover, the problems with shaping a plate are compounded when theplate has threaded holes for receiving fasteners. In distinction fromnon-fixed angle fragment plates, inserting bending tools into thethreaded holes of the plate and applying a force to the plate with thebending tools may distort the threads making such holes unaccepting totheir threaded fasteners.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to facilitate the drilling ofholes in bone in alignment with the threaded holes in a bone plate.

It is another object of the invention to obviate the difficultiespresented in connecting a drill guide in alignment with a threaded fixedangle hole in a bone plate at the time of surgery.

It is also an object of the invention to provide a system to reshape aplate while the plate is located on the bone.

It is a further object of the invention to provide a system whichpermits reshaping of the plate in three dimensions.

It is yet another object of the invention to provide a system whichprotects the threads of fixed angle holes during plate reshaping.

In accord with these objects, which will be discussed in detail below,drill guide tips are pre-assembled into at least one and preferably eachof the threaded holes of the plate, so that the surgeon does not have tothread the drill guide with the plate positioned on the bone. Thepre-assembly can be done by the operating room technician or at thefactory. The drill guide tips may be reusable or disposable. The tipsare sufficiently short that they do not interfere with adjacent tips oradjacent structure on the plate or intended to be inserted through theplate.

In a preferred method of pre-assembling the tips to the plate, a nest ofshort pins is placed beneath the plate such that the pins extend throughthe holes in the plate along the same angles as the axes of the holes.The pins then guide the tips to be threaded into the holes at thecorrect angle. Alternatively, no nest is utilized and the tips areindividually guided into the holes at the appropriate angle. Withrespect to a fragment plate, such angle is typically normal to the bonecontacting surface of the plate.

There are two options for using the tips as drill guides. One is toattach a drill guide extension. The tip and extension together functionas a conventional drill guide. After drilling, the extension is used toremove the tip from the plate. According to another use, the tip is usedas a guide for a drill bit without any additional extension and thenremoved with a separate tool.

In addition, the guide tips have purpose other than for guiding a drill.The guide tips can also be used in conjunction with plate bending tools,and are particularly advantageous when the guide tips are pre-assembledon a fragment plate having a plurality of spaced apart fixed angle holesseparated by a plate portion which can be deformed under force.Preferably two bending tools are used together to bend the plate, andthe bending tools have first and second ends which are at leastpartially inserted into guide tips in two holes in the plate. Torque isapplied by coupling the first ends of each of the tools to the guidetips inserted in threaded holes and manipulating the tools, lateralbending forces (i.e., bending within the plane of the plate) are appliedwith the second ends in the guide tips, and longitudinal bending forcesare applied with the first ends or a combination of the first and secondends in the guide tips. The bending tools can be operated and forces canbe applied to reshape the plate with the plate positioned directly onthe bone to reshape the plate in close conformance to the bone surface.As the plate is shaped at each set of two holes, bending tools areremoved and the guide tips can be used as discussed above as drillguides to drill holes into bone beneath that portion of the plate. Fixedangle screws are then used to couple that portion of the fragment plateto the bone. The adjacent portion of the plate is then shaped and fixedto the bone in a like manner with the process repeated until the entireplate is shaped and coupled to the bone.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptiontaken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a bone plate and a drill guide tip beinginserted or removed from the plate with a tool;

FIG. 2 is an exploded perspective view of drill guide tip and tool;

FIG. 3 is a perspective view of the bone plate loaded with drill guidetips and K-wires;

FIG. 4 is a front end view of a head portion of the plate showing thatthe drill guide tips do not protrude through the bottom surface of theplate;

FIG. 5 is a perspective view of a drill guide tip and drill guideextension;

FIG. 6 is a side elevation of a first embodiment of a drill guide tip;

FIG. 7 is a top view of the first embodiment of the drill guide tip;

FIG. 8 is a side elevation of a second embodiment of a drill guide tip;

FIG. 9 is a side elevation view of an embodiment of a drill guideextension;

FIG. 10 is a top view of a third embodiment of a drill guide tip;

FIG. 11 is a side elevation of a fourth embodiment of a drill guide tip;

FIG. 12 is a bottom view of an embodiment of a drill guide extensionengageable with the drill guide tip of FIG. 11;

FIG. 13 is an exploded side elevation view of a fragment plate withguide tips;

FIG. 14 is an exploded perspective view of the fragment plate and guidetips of FIG. 13;

FIG. 15 is a set of benders, shown in side elevation and perspectiveview;

FIG. 16 is a top perspective view of the benders imparting a bend alongan x-axis to impart a twist to the fragment plate along its longitudinalaxis;

FIG. 17 is a perspective view of the benders imparting a bend along ay-axis to impart a lateral bend to the fragment plate;

FIG. 18 is an enlarged view similar to FIG. 17;

FIG. 19 is a side elevation view of the benders imparting a bend along az-axis to impart a longitudinal bend to the fragment plate;

FIG. 20 is a perspective view of a fragment plate provided with anotherembodiment of a guide tip;

FIG. 21 is a top perspective view of the guide tip shown on the plate inFIG. 20;

FIG. 22 is a bottom perspective view of the guide tip shown on the platein FIG. 20;

FIG. 23 is a side elevation of an assembly of FIG. 20 with anotherembodiment of bender;

FIG. 24 is a broken bottom view of the assembly of FIG. 23;

FIG. 25 is a broken bottom perspective of the bender shown in FIG. 23;

FIG. 26 is a broken perspective view of the assembly of FIG. 23, shownapplying a bend along the y-axis to a bone plate;

FIG. 27 is a broken bottom view showing the benders applying a bendalong the y-axis to the bone plate;

FIG. 28 is a top view of the plate with bend in the y-axis applied;

FIG. 29 is an end view of the plate, guide tip, and bender assembly,with the benders applying a bend along the x-axis to the bone plate;

FIG. 30 is a broken side elevation of the assembly of FIG. 29 in whichthe benders are applying a bend along the z-axis to the bone plate;

FIG. 31 shows a single bender applying a plate bend along the z-axis;

FIG. 32 shows a single bender applying a plate bend along the y-axis;

FIG. 33 is a broken side elevation of the assembly of the benders beingused from the bottom of the plate to apply a bend along the z-axis tothe bone plate;

FIG. 34 is a side elevation of an assembly of another plate with guidetips, being bent along the x-axis by the benders;

FIG. 35 is a side elevation of the assembly of FIG. 34, in which theplate is further bent along the y-axis by the benders;

FIG. 36 is another plate according to the invention in the form of avolar T-plate; and

FIG. 37 is another plate according to the invention in the form of aclavicle plate.

DETAILED DESCRIPTION

Turning now to FIG. 1, a bone plate 10 is shown. The bone plate 10, andall plates described herein, includes inner or lower (bone-facing) andouter or upper (bone-opposing) surfaces 10 a, 10 b. One or both of thesesurfaces may be contoured generally to follow a surface of a target bone(or bones) for which the bone plate is intended, so that the bone platemaintains a low profile and fits onto the bone(s). For example, theinner surface 10 a of the plate may be generally complementary incontour to the bone surface. The outer surface 10 b may correspond incontour to the bone surface and may be generally complementary to theinner surface of the plate.

Bone plate 10 shown is particularly for placement over the volar side ofthe distal radius. The bone plate 10 includes a plurality of threadedpeg holes 12 for threadably receiving the heads of pegs or lockingscrews (not shown) therein and relatively smaller alignment holes 14sized to closely receive K-wires in a fixed angle orientation. In apreferred bone plate, the axes of the peg holes are all oblique relativeto each other. In one of the peg holes, a drill guide tip 16 is shownbeing pre-assembled into the hole with an insertion tool 18. Referringto FIGS. 1 and 2, in a preferred embodiment, the engagement between theinsertion tool 18 and tip 16 is a tapered square 20 engaging a circularopening 22, with the edges of the square driver providing sufficientfrictional force to rotate the tip into and out of engagement with theplate 10. Other suitable engagements may be used as well.

Pre-assembly of the tips 16 into the peg holes of the plate 10 ispreferably performed so that the surgeon does not have to thread thedrill guide tips 16 with the plate once the plate 10 is positioned onthe bone during the procedure. The pre-assembly can be done by theoperating room technician or at the factory. In a preferred method ofpre-assembly, a nest of short pins 24 is placed beneath the plate suchthat the pins extend through the holes in the plate along the sameangles as the axes of the holes. The pins 24 then guide the tips to bethreaded into the holes at the correct angle. With respect to a fragmentplate, such angle is typically normal to the bone contacting surface ofthe plate. The pins 24 and insertion tool 18 are sized such that they donot interfere with each other. Alternatively, no nest is utilized andthe tips 16 are individually guided into the holes at the appropriateangle. The drill guide tips 16 may be reusable or disposable.

Referring to FIGS. 2 and 3, the tips 16 have a frustoconically taperedupper portion 30 and lower threaded portion 32, and are sufficientlyshort so that they do not interfere with adjacent tips, adjacentstructure on the plate, or structure intended to be inserted through theplate, e.g., K-wires 50 through alignment holes 14. Alternatively, theupper portion 30 may be cylindrical. The lower threaded portion 32 ofthe tips does not have to be as long as conventional drill guides, asthe threading into the plate is done away from the surgical environmentunder easier conditions, whether at the factory (best case) orpre-implantation at the medical facility. Shortening the threadedportion reduces protrusion of the guide tip below the plate relative toconvention drill guides, allowing the plate 10 to sit closer to the bonewhile drilling, as discussed further below.

The drill guide tips also eliminate the need to “countersink” holes fora drill guide for the distal row of holes in a distal radius plate. Moreparticularly and for the following reasons, in the prior art it isinitially necessary to drill holes in bone through the distal row ofthreaded peg holes with a drill bit larger than the diameter of the pegshaft which will eventually be inserted through the peg holes. The plateis very thin at the distal row. The prior art drill guide has a “nose”section which is cylindrical and unthreaded and approximately 0.030″long, which is slightly longer than the pitch of the peg-hole thread(0.023″). The nose section diameter is just under the inner diameter ofthread so that it guides itself with one full turn of the thread andestablishes the direction of the hole before the threads are engaged. Ifthe plate thread depth is very small (as is the case for distal holes)there is no room below the plate for the nose section of the drill guidebecause the bone blocks entry. Thus, countersink holes must be drilled.

In accord with the invention, the drill guide tips do not require a“nose” section since they will be assembled with some other guidance(e.g., the above described nest of pins 24) or freehand. The drill guidetips can be made very short since they need just to hold on to thethreads of the peg holes of a distal radius plate. One and one-halfthreads of engagement has been shown to provide a satisfactory couplingof the tip to the plate, and referring to FIG. 4 provides that the drillguide tip 16 does not protrude through the bottom 52 of the plate 10. Inaddition to eliminating the requirement for countersinking, the factthat drill guide tips are so short results in the plate seating almostcompletely flush on the bone. Furthermore, the cylindrical unthreadednose portion of the conventional drill guide, whose only job is to helpthe surgeon find by feel the current angle of the peg hole, is notrequired. A preferred size for each tip is preferably approximately0.150-0.250 inch in length and certainly less than one inch. As such,the tip extends a short distance (maximum one inch and preferably notmore than 0.25 inch) above the upper surface (the surface opposite thebone contacting surface) of the plate.

There are two options for using the tips as drill guides. According to afirst option, the tips 16 are used as the sole guide for a drill bit andthen removed with a tool similar to the insertion tool 18. The length ofthe tips provides sufficient guidance for the drill bit. In this use,the inner surface of the tip is preferably hard, e.g., metal. Thus, thetips 16 may be made entirely of metal or have an outer plastic body withan insert molded metal tube, e.g. hypotube, which is hard and readilyavailable with thin walls.

Referring to FIG. 5 and according to a second option, a drill guideextension 34 may be attached to the top of the tip 16. The tip 16 andextension 34 together function as a full length drill guide. Theengagement between the drill guide extension 34 over the tip 16 ispreferably such that a continuous constant diameter path is providedthrough the interiors of the extension and tip. To that end, the end 36of the extension 34 is preferably stepped to fit the upper portion ofthe tip. The surgeon drills through the drill guide extension and tip,thereby taking advantage of the longer guidance which may be used inconjunction with a scale and/or gauge to measure the depth of thedrilled hole for peg length selection. After drilling, the extension 34and tip 16 are removed from the plate 10, and the extension 34 may alsofunction as a tool for tip 16 removal. In fact, the taper at the upperportion 30 (FIG. 2) of the tip provides a means for axial and frictionalengagement by the extension 34 which permits rotational engagement. Onceremoved from the plate, the tip is then is pulled of the extension byhand or may be dispensed into a container without manual contact.

It is desirable to have some provision within the surgical set tocollect the tips for counting as they are removed; i.e., to ensure thatall tips from the plate are removed from the surgical site. In order tofacilitate collection of the tips, it is desirable that the drill guidetips have a very conspicuous color, e.g., green or blue. If made out ofmetal, it may be desirable to make them out of titanium or aluminum andanodize them in a bright color that contrasts with the background in thesurgical wound and the bone plate. A specialized container may beprovided, or a dummy plate with threaded holes may be used to attach thetip thereto.

For drilling through the tips 16 where no drill guide extension is used,it may be desirable to modify the flutes of the drill bit, e.g.shortening and/or increasing twist, to reduce the play within the tip.

Other embodiments of the tips and extensions may be provided. Forexample, referring to FIGS. 6 and 7, the tips 116 may have an upperportion 130 with an exterior hex shape, or any non-circular exteriorcross-sectional shape that will facilitate torque transmission. Toremove the tip from the plate the surgeon rotates the extension,unthreading the tip.

Turning now to FIGS. 8 and 9, according to another embodiment of theinvention, the tips 216 may be joined to the extension via one or morelateral protrusions 240 on the body 230 of the tip and corresponding“key slots” 242 in the extension 234.

Referring to FIG. 10, according to a further embodiment of theinvention, the tips 316 may be joined to the extension by providing oneor more corners 344 to the inner circular opening 322 of the tip, andone or more outer corresponding corners on the extension whichfrictionally engage in the tip.

Turning to FIGS. 11 and 12, according to another embodiment of theinvention, the tips 416 may include upper radially arranged slots 446(e.g., 180° or 120° separation) and the extension 434 includescorresponding radially arranged pegs 448 which engage the tips 416 atthe slots 446.

Turning to FIGS. 13 and 14, the tips can also be used to facilitatebending of a fragment plate 500 in a manner that does not distort thethreads at the holes 502 at which the tips 516 are coupled, as describedbelow. The tips 516 are cylindrical having inside corners (similar tocorners 344 in FIG. 10) to aid removal and/or extension guide coupling.Such distortion would otherwise prevent the holes 502 from acceptingfixed angle fasteners with threaded heads which are later threadablycoupled into the threaded holes.

Bendable plates, as described in more detail below, according to theinvention may have at least one, and generally two or more, distinctanchor (or bone-attachment) portions including a threaded hole and atwhich the plate is configured to be secured to bone. Each anchor portionmay be structured for a specific portion of a bone, generally to fitagainst a surface region of a specific or general bone. For example, thebone plate may include a proximal anchor portion for attachment to amore proximal region of a bone, and a distal anchor portion forattachment to a more distal region of the same bone. In someembodiments, the bone plates may include a support (or buttress) portionconnected to an anchor portion. The support portion may lack connectivefeatures that permit a direct connection of the support portion to thebone with one or more fasteners. Such a support portion may limitmovement of a bone fragment using contact between the support portionand the fragment, and may include projections or prongs to engage thefragment more effectively.

The bone plates described herein may be configured for use on anysuitable bone of the human body and/or of another vertebrate species.Exemplary bones may include bones of the arms (radius, ulna, humerus),legs (femur, tibia, fibula, patella), hands, feet, the vertebrae,scapulas, pelvic bones, cranial and mandibular bones, the ribs and/orthe clavicles, among others.

The fragment plate 500 is generally elongate, preferably designed with aseries of alternating round anchor portions 504 and relatively narrowerbridge portions 506 that connect the anchor portions together. Theanchor portions 504 have a diameter D_(A) and a height H_(A), and thebridge portions 506 have a length L_(B), a width W_(B), and heightH_(B). By way of example, and not by limitation, the followingdimensions are provided for a plate for use on a radius bone: diameterD_(A)=0.22 inch, H_(A)=0.060 inch, L_(B)=0.065 inch, W_(B)=0.085 inch,and H_(B)=0.50 inch. To maintain structural integrity and desiredstiffness, while facilitating bendability, the length L_(B) of eachbridge portion is preferably less than one half, and more preferablyless than forty percent, of the anchor diameter D_(A). The plateincludes an inner (bone-facing) surface 512 and an outer (bone-opposing)surface 514. In use, a long axis A_(p) defined through the plate 500 maybe aligned with the long axis of a corresponding bone or may extendobliquely or transversely relative to the long axis of the bone. Thedimensions of the anchor and bridge portions 504, 506, and the number ofanchor and bridge portions, may be varied according to the intended use,for example, to match the plate with a preselected region of bone(s)and/or to a particular injury to the bone. The plates may be generallylinear for use on the shaft of a long bone or may have a nonlinearshape, such as for use near an end of a bone. For example, the plate maybe generally T-shaped, with a longer axis for attachment to a shaftportion of a bone, and a transverse portion connected to the longer axisportion, to provide a wider platform for attachment near an end of thebone. Also, by way of example, the transverse portion may be of adifferent construct, e.g., a plate portion without any bridge portionsbut multiple threaded holes, as shown in FIG. 1. The plate may also beY-shaped. In some embodiments, each bone plate may be configured for useon both sides of the body, such as when the bone plates are bilaterallysymmetrical. In some embodiments, each bone plate may be asymmetricaland configured for use on either the left or the right side of the body.

Threaded holes 502 are provided in the anchor portions 504, andpreferably each threaded hole 502 is provided with a guide tip 516.However, the tips may be strategically pre-assembled at locations thatare recognized to commonly benefit from contour shaping for the plate500 depending on the shape of the plate and to best fit on the bone.

Referring to FIG. 15, two preferably identical plate benders (shapingtools) 550 a, 550 b have ends which can be coupled to the tips 516 andcan be used alone or together to contour the plate 500 (FIGS. 13 and14). As described in more detail below, the benders 550 a, 550 b andtips 516 permit such plate contouring to occur with the plate 500positioned directly on the bone. Each tool, described with respect totool 550 a, includes a handle portion 552 a and first and second ends554 a, 556 a which can be at least partially inserted into the guidetips 516. The first end 554 a includes a preferably axially directed (orpreferably at least directed generally parallel to the longitudinal axisA_(L) of the handle portion 552 a) peg element 558 a which closelycorresponds in size to the inner diameter of a guide tip 516. The secondend 556 a is provide with four peg elements 560 a, 562 a, 564 a, 566 a,with two such pegs extending transversely to the longitudinal axis A_(L)of the handle on each side 568 a, 570 a of the second end 556 a. At onesuch side 568 a, the endmost peg element 560 a closely corresponds insize to the inner diameter of a guide tip 516 and the inner peg element562 a has a stepped down nipple portion 572 a, whereas on the oppositeside 570 a of the second end the endmost peg element 564 a has a steppeddown nipple portion 574 a stepped down in diameter and the inner pegelement 566 a closely corresponds in size to the interior of the guidetip 516. All the peg elements are preferably generally cylindrical, butmay be polygonal or slightly tapered.

As described as follows, the benders 550 a, 550 b can be coupled to afragment plate at the guide tips 516 to apply torque, lateral andlongitudinal bending forces to contour the plate; i.e., to bend theplate along x-, y- and z-axes. In the present embodiment it is preferredthat the benders be coupled at adjacent guide tips for localized controlof plate shaping. The plate is then shaped through a series of shapingsteps in which adjacent portions of the plate are sequentially shaped,as needed. Additionally all such shaping, as also discussed furtherbelow, can be performed while the plate is positioned on the bone.

Referring to FIG. 16, in order to apply torque to the plate to cause theplate to twist, the peg elements 558 a, 558 b (FIG. 15) at the firstends 554 a, 554 b of the benders 550 a, 550 b are inserted intopreferably adjacent guide tips 516 a, 516 b. The handle portions 552 a,552 b of the benders are then forced laterally relative to each other soas to apply a torque along the bridge portion 506 of the plate betweenthe benders. Such torque results in defining a twist in the platewithout deformation to the threaded holes to bend the plate along thex-axis.

Referring to FIGS. 17 and 18, lateral bending forces (i.e., bendingwithin the plane of the plate) are applied with the second end 556 a,556 b of the benders 550 a, 550 b coupled to the guide tips 516 a, 516b, and then manipulating the benders to bend the plate about the y-axis.Referring to FIG. 18, more particularly, on bender 550 a, peg element566 a (see FIG. 15) is inserted into guide tip 516 a and the nippleportion 574 a of peg element 564 a functions as fulcrum (rotationalstop) against the bridge portion 506 a of the plate to transferrotational forces applied by the handle portion 552 a of bender 550 a.On bender 550 b, peg element 560 b (not shown, see FIG. 15) is insertedinto guide tip 516 b and the nipple portion 572 b of peg element 562 bfunctions as a fulcrum (rotational stop) against the bridge portion 506b of the plate to transfer rotational forces applied by the handleportion 552 b of bender 550 b. As benders 550 a, 550 b are operatedtogether, the resulting force subjects the plate to lateral bending atthe bridge portion 506 a located between the plate portions 504 a, 504 bat which the guide tips are coupled.

Referring to FIG. 19, longitudinal bending forces are applied byinserting the peg element at the first end 554 a of bender 550 a intoguide tip 516 c and a peg element, e.g. peg element 560 b, at the first554 b or second ends 556 b (shown) of the second bender 550 b into theguide tip 516 d. With the second end 556 b coupled at guide tip 516 d,the handle portion 552 b thereof can be stabilized relative to the bone.The handle portion of tool 550 a is then manipulated to bend the plate500 at the bridge portion 504 between the two benders to bend the platerelative to the z-axis.

It is also appreciated that a single bender can be used to shape theplate once at least a portion of the plate is fixed relative to thebone. Such is described in more detail below with reference to anotherembodiment of a bender.

Because the benders are not coupled at any locations below the surfaceof the plate nor do they have any portion which would otherwiseinterfere with the bone or bone contacting surface, plate shaping canoccur directly on the bone. In one method of operation, a hole is firstdrilled through a guide tip at an end of the plate. The guide tip isthen removed and a threaded fastener is inserted through the threadedhole of the fragment plate and into the drilled hole to couple the plateto the bone. The benders are then worked along the plate, moving hole byhole away from the first coupled hole to shape the plate to the bone asdescribed above. As the plate is shaped at each hole, if needed, a holeis drilled through the respective guide tip, the guide tip is removedand a threaded fastener is inserted to hold the plate to the bone. Oneor both of the benders are then moved to subsequent holes along theplate for shaping until the plate is fully contoured and coupled to thebone. In another method, after the plate is coupled to the bone at anend, the plate is shaped along its entire length prior to coupling tothe bone at remaining holes. In yet another embodiment, the plate may beshaped to the bone before it is attached at any screw hole. It isrecognized that other variations on shaping and coupling can be used.

Turning now to FIG. 20, a shapeable bone plate 600 is shown with anotherembodiment of the guide tips 616. The plate is substantially asdescribed above with respect to plate 500, including an alternatingarrangement of anchor and bridge portions 604, 606. Each anchor portion604 is preferably curved along a constant radius for at least 100°adjacent its adjacent bridge portion, and more preferably approximately120°, for cooperation with another embodiment of a plate bending tool650 a, 650 b, described hereinafter.

Referring to FIGS. 20 through 22, the guide tips 616 each have a firstend 618 assembled in a threaded hole in the anchor portion 604, a secondend 620 extending above an outer surface 614 of the anchor portion, anda circumferentially extending shoulder 622 disposed between the firstand second ends, and preferably in contact with outer surface 614 of theplate 600. The shoulder 622 doubles the load carrying capacity of theguide tips 616 relative to the prior guide tips by reducing the loadcarrying from the thread/thread interface and transferring load carryingto the shoulder/plate interface. The second end 620 of the guide tip 616preferably extends no more than 0.5 inch, and more preferably is locatednot more than approximately 0.25 inch above the outer surface 614 of theanchor portion.

Referring to FIG. 23, a pair of plate benders 650 a, 650 b is showncoupled to adjacent anchor portions 604 a, 604 b of the plate 600. Theplate benders 650 a, 650 b each include a first end 652 a, 652 b, asecond end 654 a, 654 b, and a handle 656 a, 656 b extendingtherebetween, with the respective handles 656 a, 656 b preferablyextending in generally opposing directions. Referring to FIGS. 23through 25, the first end 652 a defines a socket 660 a sized to closelyreceive a guide tip 616, and means for rotationally fixing the first end652 a relative to a portion of the bone plate 600, such as the bridgeportion 606. In a preferred embodiment, the means for rotationallyfixing the first end relative to the bone plate are two feet 662 a, 664a that straddle the bridge portion 606 of the bone plate. The two feet662 a, 664 a include curved inner surfaces 666 a, 668 a that seat aboutthe radiused portions 670, 672 of the anchor portion 604 a to quicklyand easily align the bender 656 a on the plate. The feet 662 a, 664 aeach have a toe end 674 a, 676 a that abuts the bridge portion 606 at anoptimal location to function as a fulcrum for the bender. Referring backto FIG. 23, the second ends 654 a, 654 b of the benders define pegs 678a, 678 b that are cylindrical and that step down in diameter from theadjacent portion of the handle. The handle 656 a, 656 b is preferablyL-shaped and extends between the respective first and second ends. Eachhandle, e.g., 656 a, includes a first longitudinal axis A₁ extendingthrough its first end 652 a and an adjacent portion of the handle and asecond longitudinal axis A₂ extending through the second end 654 a andits adjacent portion of the handle. The handle 656 a is preferably bentto offset the two axes relative to each other. Most preferably, thesocket 660 a at the first end 652 a is offset relative to the secondaxis A₂ by at least approximately 0.25 inch, more preferably at least0.5 inch (to provide for guide tip and tissue clearance), but preferablyby not more than approximately 3 inches (to maintain handle stabilityand control). It is noted that the benders 650 a, 650 b are preferablyidentical with the exception that the handles are bent in oppositedirections from each other. The handles are coupled to the plate suchthat the longitudinal axis A₁ of each handle overlies the respectivelongitudinal axis of the plate portions surrounding the plate segmentwhich is to be bent. An exception is provided at the anchor portion 604a at the end of the plate, where the appropriate bender should becoupled so that the handle extends outward from the plate, rather thanover the plate.

The plate 600 is generally bent so that its inner surface 612 thereofapproximates the shape of the bone surface generally in the mannerdescribed above. More particularly, referring to FIGS. 26 and 27, a bendin the y-axis may be imparted to the plate at the bridge 606 betweenanchor portions 604 a, 604 b to which the benders 650 a, 650 b arecoupled by applying a relative rotational force. In imparting such abend, the feet 662 b, 664 b of bender 650 b stabilize anchor 604 b,while the toe 674 a of foot 662 a functions as a fulcrum and the innersurface 668 a of the opposite foot 664 a applies the force to the anchorportion 604 a to impart the desired bend. Without relocating the bender,force could be applied in an opposite rotational direction and theopposite feet would perform reverse functions. Each foot also functionsas a stop to limit angular displacement to approximately 40°. The ‘stop’function is effected in that the toe end of the foot operating as afulcrum contacts the adjacent anchor portion after approximately 40° ofangular displacement and limits any further angular movement of theanchor portions relative to each other. FIG. 28 shows the plate 600 witha lateral bend imparted between anchor portions 604 a and 604 b afterthe benders have been removed from the plate.

In addition, the pegs 678 a, 678 b at the second ends of the benders canbe inserted into the guide tips 616 at preferably adjacent anchorportions and can be manipulated to bend the plate relative to x- andz-axes; i.e., to impart torque and a resulting twist to the plate(x-axis displacement) and to longitudinally bend the plate up and/ordown (z-axis displacement). FIG. 29 shows the benders 650 a, 650 bimparting a twist to the plate 600; i.e., to rotate anchor portion 604 ain the x-axis relative to anchor portion 604 b. It is appreciated thatthe benders may similarly be used to bend the plate along the z-axis.

However, it is also recognized that the benders could possibly interferewith each other when the necessary z-axis bend requires moving thebenders toward each other in the same plane. Referring to FIG. 30, oneway to overcome any potential interference is to move the benders 650 a,650 b out of plane, but this may impart an x-axis twist to the plate600, which could be undesired. Turning to FIG. 31, one solution whenworking in from the end of the plate (the ends of which are alreadyfixed to the bone 680 by screws 682) is to use a single bender 650 a toimpart a bend along the z-axis. Similarly, referring to FIG. 32, a bendalong the x-axis can likewise be imparted. Referring to FIG. 33, anothersolution is to insert the pegs 678 a, 678 b (FIG. 23) of the bendersinto the guide tips 616 from the bottom 612 of the plate and thenmanipulate the benders 650 a, 650 b away from each other to effect abend about the z-axis without any bend about the x-axis. While it isrecognized that the plate cannot be coupled to the bone during this typeof bending, it nevertheless may be desirable to make certain grosscontour adjustments with the plate located off the bone, e.g., prior toapplying the plate to the bone.

In most instances, it is preferred that the bridge portion of the platebe substantially narrower than the anchor portion to facilitate bending,particularly a lateral bend along the y-axis. Nevertheless, it isappreciated that plates with smaller ratios of anchor to bridge widthscan also be bent and shaped using the guide tips and tools describedherein, and there are circumstances where an overall relatively stifferplate may be desirable. For example, referring to FIGS. 34 and 35, aY-shaped plate 700 with such a smaller ratio is shown first beingtorqued along the x-axis to impart a twist (FIG. 34) and then being bentalong the z-axis to impart a longitudinal bend (FIG. 35) in accord withthe methods described above. In such a stiffer plate 700, it ispreferable to position the benders 650 a, 650 b in guide tips that arespaced apart by at least one threaded hole.

Also, while shapeable plates described above have a construct ofalternating anchor and bridge portions, it is recognized that hybridplates may be provided that have both shapeable and relatively stiffernon-shapeable portions. Such plates are anticipated to be fracturespecific and are rigid where the anatomy is relatively constant incontour across patients and shapeable where there may be individualvariations in bone surface anatomy. For example, referring to FIG. 36, avolar T-plate 800 is shown in which the axial shaft portion 802 isshapeable and provided with guide tips 816. In addition, the relativelytransverse head portion 803 is substantially non-shapeable, with theexception of an anchor portion 804 coupled by a bridge 806 to theremainder of the head portion 803. The anchor portion 804 is thusadapted to be shaped relative to the rest of the head portion to directa fastener toward the volar marginal fragment. Preferably all the holesin the head portion are provided with guide tips 817. Guide tips 816 and817 may be different sizes to accommodate relatively different diameterthreaded holes in the respective portions of the plate. When the guidetips are removed from the head portion 803 and subchondral supports 818(e.g., threaded pegs or screws) are inserted into the threaded holestherein, any load on the subchondral supports is transferred back to theaxial shaft portion 802 of the plate 800. The same principal can beapplied to other metaphyseal plates. By way of another example, aclavicle plate 900 is shown in FIG. 37. The clavicle plate 900 has arelatively rigid non-shapeable central portion 902, and end portions 903that are shapeable. The same principal can be applied to otherdiaphyseal places.

There have been described and illustrated herein several embodiments ofa bone plate with pre-assembled guide tips, benders for use with a platewith guide tips, and methods of using the same. While particularembodiments of the invention have been described, it is not intendedthat the invention be limited thereto, as it is intended that theinvention be as broad in scope as the art will allow and that thespecification be read likewise. Thus, while the tips and benders havebeen shown with respect to a volar plate for dorsally displacedfractures and several fragment plates, it will be appreciated that thetips may be used in conjunction with threaded holes on other bone platesas well. For example, the tips may be used in conjunction with any platefor which they would provide advantage. In addition, one or more bendersmay be used to customize a fracture fixation plate for other bones,e.g., the clavicle, the ulna, the olecranon, the jaw, the skull, whethersuch plates are pre-formed flat or contoured to fit the anatomy.Furthermore, a distal radius plate having radial and ulnar sidesprovided with threaded fixed angle holes, the radial and/or ulnar sidesbeing provided with guide tips and being shapeable with the benders, isconsidered within the scope of the invention. Also, a distal radiusplate having shapeable segment(s) for capturing a volar marginalfragment is also within the scope of the invention. Optionally, suchshapeable segment(s) may be removable from the plate if not used, e.g.,by repeated bending, and provide a relatively clean break with theplate. In addition, while particular engagements between the tips andthe insertion/removal tool and the tips and drill guide extension havebeen disclosed, it will be understood that other suitable engagements,including non-destructive press-fit, snap-in, bayonet lock, etc. canalso be used. Also, while the guide tips are described as threaded intothe threaded holes, it is appreciated that non-threaded assemblies,including non-destructive press-fit, snap-in, bayonet lock, etc., whichmaintain the tips in alignment with the axes of the peg holes can alsobe used. While different benders have been shown, each can be used withmultiple embodiments of the guide tips. With respect to the benders withmultiple peg elements, preferred orientations of the peg elements havebeen described, but other configurations are possible within the scopeof the invention. For example, the four peg elements can be located twoeach at, e.g., 90° apart. In addition, such benders may only have twopeg elements at a second end, each with a different configuration oflarger and smaller size peg elements. Furthermore, while it is preferredto work a plate for shaping by coupling the benders at guide tips atadjacent holes, it is appreciated that not all holes of a shapeableplate need be provided with a guide tip and that the benders may be usedrelatively more spaced apart along the plate regardless of whether allholes of a shapeable plate include guide tips. Moreover, while it ispreferable that the plate be coupled to be bone with bone screws whileit is shaped relative to the bone, it is appreciated that the plate maybe coupled to the bone with temporary fixation, such as with one or moreclamps, during shaping. Furthermore, while the bendable plate segmentsare preferably bridge portions narrower than the surrounding anchorportions, it is appreciated that the one or more bendable segments maybe of a different configuration than shown, provided that they are lessrigid than the surrounding plate portions and are structured to deformprior to destruction of the plate threads in which the guide tips arethreaded. It will therefore be appreciated by those skilled in the artthat yet other modifications could be made to the provided inventionwithout deviating from its scope.

What is claimed is:
 1. A fracture fixation plate shaping kit,comprising: a) a bone plate including a plurality of longitudinallydisplaced threaded holes; b) a plurality of tubular elements which canbe coupled in the threaded holes and removed therefrom; c) a firstshaping tool having a handle portion and an end portion sized and shapedto engage with one of the tubular elements; and d) a second shaping toolhaving a handle portion and an end portion sized and shaped to engagewith another of the tubular elements, the first and second shaping toolsbeing capable of engaging the tubular elements for the manualapplication of force to the bone plate to bend the bone plate.
 2. A kitaccording to claim 1, in which the plate has a bone contacting surfaceand an opposite surface, and each of the tubular elements has a firstend which is coupled to the plate and an end opposite the first endwhich is located not more than approximately 0.25 inch from the oppositesurface of the bone plate.
 3. A kit according to claim 2, in which thefirst end of each of the tubular elements is a threaded end.
 4. A kitaccording to claim 2, in which the tubular elements having an innerdiameter, and the end portion of each of the first and second shapingtools includes a portion which closely corresponds in size to the innerdiameter for insertion therein.
 5. A kit according to claim 2, in whichthe end portion of at least one of the shaping tools includes a pegextending parallel to a longitudinal axis of the shaping tool, the peghaving a diameter which closely corresponds in size to an inner diameterof the tubular elements.
 6. A kit according to claim 2, in which the endportion includes two parallel spaced apart peg elements, at least one ofwhich closely corresponds in size to an inner diameter of the tubularelements.
 7. A kit according to claim 6, in which one of the pegs isstepped in diameter.
 8. A kit according to claim 7, in which the pegstepped in diameter is spaced closer to an end of the end portion.
 9. Akit according to claim 7, in which the peg which is stepped in diameteris spaced further from an end of the end portion.
 10. A kit according toclaim 6, in which the end portion includes four pegs arranged in firstand second sets of two, in which one of the pegs of the first set isstepped in diameter, and in which one of the pegs of the second set isstepped in diameter and spaced further from the end of the end portionthan the stepped peg of the first set.
 11. A kit according to claim 10,in which the four pegs are arranged so that they are approximatelyparallel to one another.
 12. A kit according to claim 6, in which thefirst shaping tool includes another end portion including a pegextending parallel to a longitudinal axis of the shaping tool.
 13. A kitaccording to claim 1, in which the end portion of at least one of theshaping tools defines a socket into which a portion of the tubularelement is received.
 14. A kit according to claim 13, in which thesocket is sized relative to the portion of the tubular element so thatthe portion of the tubular element is closely received in the socket.15. A kit according to claim 14, in which each of the first and secondshaping tools defines a respective socket.
 16. A kit according to claim1, in which the bone plate includes alternating anchor portions andnarrower bridge portions bridging the anchor portions, the threadedholes located in the anchor portions.
 17. A kit according to claim 16,in which the anchor portions are rounded.
 18. A kit according to claim16, wherein when the first and second shaping tools are engaged to thetubular elements, sufficient manual application of force to the shapingtools results in bending of the bone plate across a bridge portionlocated between the anchors portions at which the tubular elements arecoupled.
 19. A fracture fixation plate shaping kit, comprising: a) abone plate including a longitudinal displacement of alternating anchorportions and narrower bridge portions bridging the anchor portions, anda threaded hole located in each of the anchor portions; b) a pluralityof tubular elements which can be threadedly engaged in the threadedholes and removed therefrom; c) a first shaping tool having a first endportion defining a socket sized and shaped to engage with one of thetubular elements; and d) a second shaping tool having a first endportion defining a socket sized and shaped to engage with another of thetubular elements, the first and second shaping tools being capable ofengaging the tubular elements for the manual application of force to thebone plate to bend the bone plate at a bridge portion between the anchorportions at which the tubular elements are threadedly engaged.
 20. A kitaccording to claim 19, in which the plate has a bone contacting surfaceand an opposite surface, and each of the tubular elements has a threadedend which is coupled to the plate and a guiding end opposite thethreaded end which is located not more than approximately 0.25 inch fromthe opposite surface of the bone plate.
 21. A kit according to claim 19,in which the plate has a bone contacting surface and an oppositesurface, and each of the tubular elements has a threaded end which iscoupled to the plate and a guiding end opposite the threaded end, thetubular element defining a body portion between the plate and theguiding end that has a cylindrical exterior surface.
 22. A kit accordingto claim 19, in which the first shaping tool includes a second endhaving a peg with a diameter which closely corresponds in size to aninner diameter of the tubular elements and the second shaping toolincludes a second end with a peg which closely corresponds in size to aninner diameter of the tubular elements.
 23. A kit according to claim 22,in which the first shaping tool defines a longitudinal axis and the pegat the second end thereof extends parallel to the longitudinal axis ofthe first shaping tool, and second shaping tool defines a longitudinalaxis, and the peg at the second end thereof extends parallel to thelongitudinal axis of the second shaping tool.